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WOLVES IN SHEEP'S CLOTHING - The Dangerous World of Unlicensed, Fake and "Copycat" Generic Drugs and Dietary Supplements

Aug 1, 2002 PART II - INTRODUCTION

In our last Newsletter (Part I), we discussed a number of herbal and vitamin supplements that have caused great concern in both the United States and abroad. Since the publication of that Newsletter, Germany has announced a ban on KAVA as a result of 40 cases of severe liver toxicity. Six of these cases led to complete liver failure requiring an organ transplant and three cases resulted in death. While in most cases those suffering liver damage recovered after use of the supplement ceased, consumers should be aware of these adverse side effects and consult a physician before using KAVA supplements.

Part II of this Newsletter deals with "prescription" drugs which, because of their highly questionable origin or manufacture, present the public with significant health risks. The categories we will deal with are (1) fake (counterfeit) drugs; (2) unlicensed drugs; (3) cheap "copycat" drugs; and (4) prescription drugs that turn up in dietary supplements.

FAKE DRUGS

Recently, a variety of fake, or counterfeit, drugs have found their way into pharmacies in the United States. Although there have only been a limited number of cases involving these counterfeit prescription drugs, consumers should still be wary when purchasing these particular drugs. U.S. Customs Services, in association with Congress and the Food and Drug Administration, have done their part in preventing most of these drugs from reaching our neighborhood drug store. "But, there is no way of knowing what we are not catching." says Paul K. Schwartz, director of trade enforcement at the Customs Services. In 1998, U.S. Customs seized 2,145 parcels of prescription drugs. In 1999, that figure increased to 9,725. These seizures consisted largely of shipments to individuals who had ordered drugs from websites outside the United States. However, some of the seizures were of the commercial variety intended for resale to the public.

Consumers should be aware of three injectable drugs in particular:

1. Serostim - a growth hormone used by AIDS patients and sold by Serono.2. Nutropin - a growth hormone sold by Genetech.3. Neupogen - a cancer drug sold by Amgen.

Due to the fact that all of these drugs are very expensive, they are prime targets for counterfeiting. A 12-week course of Serostim, for example, costs approximately $12,000. Consumers are generally interested in purchasing them at a cheaper price. Serostim and Nutropin are promoted for sale, without a prescription, on some websites with claims that the drugs will help users to lose weight, build muscle and smooth wrinkles. Counterfeiters also favor prescription drugs because their small size makes smuggling them into and around the United States less risky. Moreover, once the drugs pass from distributor to distributor, and warehouse to warehouse, the origin of any particular batch becomes difficult to trace. The fact that the fake drugs are very similar in appearance to the real ones and, in some cases, actually bear real lot numbers, adds to the difficulty in detecting the counterfeits. Some of the fake packages of the real drugs contain cheap generic versions of the product.

Since there is an ongoing investigation, the FDA cannot discuss many aspects of these cases. However, counterfeit versions of Serostim have been found in at least seven states where users have complained of swelling and skin rashes after being injected. In May of 2001, counterfeit Neupogen was discovered in Florida, Indiana and California. In some cases, the fake drug was nothing more than a clear liquid without any drug in it at all while in another case, the drug was actually human insulin. Obviously, in certain situations the fake drugs can pose a serious or even life-threatening health risk.

If you or someone you known have used, or are currently using, any of these drugs, or are experiencing, or have experienced, any unusual side-effects, preserve any remaining doses of the medication and consult your physician immediately.

UNLICENSED DRUGS

Unlicensed prescription drugs are often found in poorer neighborhoods being sold door to door and in places such as bodegas. They are particularly popular in such communities since the people there are the most likely not to have health insurance or the resources to pay for the medical visits needed to obtain a prescription. In ethnic-based neighborhoods there is also the problem of language barriers and reliance upon "medical" advice that is passed along by rumor.

One of the unlicensed drugs is a form of ampicillin called Ampitrex (an antibiotic similar to penicillin) that is made in the Dominican Republic by Feltrex Laboratories. Ampitrex is not licensed for use in the United States, however, in neighborhoods such as Washington Heights in New York City, Ampitrex can be found in all types of stores and is usually sold two pills for $1.00. Ampitrex is sold in the Dominican Republic without a prescription and, as a result, is often misused by taking it when it is not needed, or in the wrong dosages, or for too short a period of time to be effective.

Despite the illegal importation and sale of such drugs, antibiotics are simply not a high priority for the Customs Service. In fact, in the 33rd Precinct in New York City that includes Washington Heights, there has never been a single antibiotics arrest according to a New York Times article (2/10/02) by F. Brunder and G. Chandler.

Consumers who choose to make use of these over-the-counter prescription antibiotics and other drugs should be aware, however, that misusing antibiotics could be dangerous. These drugs are used casually to treat a wide variety of symptoms and many consumers are not sure quite how to use them properly. While prescription drugs and a visit to the doctor may be expensive, experimenting with these unlicensed prescription drugs may have a much more costly effect in the long run - one which will compromise your health and well-being.

CHEAP, "COPYCAT" GENERIC DRUGS

A very peculiar problem in the world of prescription drugs has developed with respect to the manufacture of cheap generic "copycat" drugs in India. Under Indian law, a patent (in chemicals, medicine and agriculture) covers only the actual manufacturing process and NOT the product itself. Thus, chemists in India are free to "reverse-engineer" any product by performing a chemical analysis on it and then duplicating it by a somewhat different process. In fact, Indian chemists have duplicated the entire product line of certain pharmaceutical companies.

In this way, Indian chemists can target specific, highly profitable drugs that have been developed only after years of research and at a cost of hundreds of millions of dollars, and simply copy their chemical composition without fear of intervention by the Indian government. The company that developed and patented the drug is then forced to watch its profits eroded by the sale of the "copycat" version of the product. This can be catastrophic for some companies when the huge cost of developing a drug cannot be recovered. To be sure, legitimate pharmaceutical companies regard this situation as nothing more than piracy and stealing.

The problem with all of this, besides the obvious economic damage, is that there is no uniformity in quality control among the 20,000 drug companies in India. Thus, counterfeiting is widespread and the quality of any copied product is difficult, if not impossible, to guarantee.

DIETARY SUPPLEMENTS (with unexpected ingredients)

A recent discovery with serious implications is that prescription drugs have been found in dietary supplements and other herbal products. Earlier this year in California, consumers were warned to stop using herbal products known as PC SPES and SPES, dietary supplements used to help treat prostate cancer. In a laboratory analysis of the products, PC SPES was found to contain warfarin, an anticoagulant (blood thinner) that can lead to uncontrolled bleeding when used improperly and SPES contained alprazolam (a/k/a Xanax) which causes drowsiness and can lead to dependence. In certain cases, older lots of PC SPES also contained indomethacin, an arthritis drug, and diethylstilbestrol (DES).

SPES is composed of various herbs, and is intended to help support the body after long term weakness such as that which arises during cancer treatments. It is not supposed to contain any artificial ingredients and therefore the detection of these prescription drug elements was a complete shock to the manufacturers.

Consumers who have been using PC SPES and SPES should return them to:

PC SPES Recall Program2900-B Saturn StreetBrea, CA 92821

For further information, call the California Department of Health Services (800) 495-3232. You should always consult your physician before using any dietary supplement.

We hope that the information contained in this two-part Newsletter has been of interest to our subscribers and that it may have saved at least one person from making a serious mistake in the purchase or use of the products discussed.

For further information regarding the rights you or your loved one may have with respect to this matter contact PARKER & WAICHMAN immediately by calling 1-800-YOURLAWYER or visiting http://www.yourlawyer.com.

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